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Neurodegenerative DiseasesEVOCADNCT04229186

Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients

A study testing EVOO-C and ROO in people with Neurodegenerative Diseases, run by University of Bari Aldo Moro.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Neurodegenerative Diseases
What is being tested?
EVOO-C and ROO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Jan 2020to Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MCI diagnosis in the last month prior the recruitment;
  • Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;

Who cannot join

  • smoke;
  • hypertension;
  • diabetes;
  • positive history of stroke, epilepsy or cardiac disease;
  • BMI > 30;
  • depression or other psychiatric disturbances;
Show all 11Show fewer
  • low compliance to medical interventions;
  • positive history of olive oil allergy or intolerance;
  • positive history of chronic inflammatory intestinal disease or malabsorption;
  • positive history of maculopathy or retinopathy;
  • MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions

About this study

Official title: Pilot Study About Extra Virgin Oil "Coratina" (Evoo-c) in Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (EVOO-c in MCI/AD)

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.

Read the detailed description

24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on:

  • neurological examination (T0, T6, T12);
  • cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed;
  • ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed;
  • neuropsychological assessment (T0, T12);
  • nutritional assessement(T0, T3, T6, T9, T12).

Each subject will perform:

  • brain MRI (T0, T12);
  • Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).
Being tested
EVOO-C, ROO
Keywords
Mild Cognitive Impairment, Alzheimer's Disease, Extra Virgin Olive Oil
Medical subject headings
Neurodegenerative Diseases, Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVOO-CDietary supplement

    Each patient will consume 10 mg total daily amount EVOO-C

  • ROODietary supplement

    Each patient will consume 10 mg total daily amount ROO

Study groups in NCT04229186
Study groupRoleWhat they receive
Patients with assumption of EVOO-CExperimental12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C
Receives: Dietary Supplement: EVOO-C
Patients with assumption of ROOExperimental12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO
Receives: Dietary Supplement: ROO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the change of cerebral performance after olive oil supplementation.

    The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)

    Measured: Change from baseline MMSE score at 12 months

  2. Evaluate the change of nutritional parameters after olive oil supplementation

    Weight and height will be combined to report BMI in Kg/m^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.

    Measured: Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months

  3. Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.

    Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analisys (cerebrospinal level of Beta-amiloid, Tau and phospotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))

    Measured: Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months

  4. Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.

    Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))

    Measured: Change from baseline neurodegenerative biomarkers at 12 months

  5. Evaluate the change of optic nerve and macula thickness after olive oil supplementation.

    Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)

    Measured: Change from baseline optic nerve and macula thickness at 12 months

  6. Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.

    Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)

    Measured: Change from baseline at 12 months

  7. Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.

    Beta amyloid positron emission tomography will be performed measuring a index called BAPL.

    Measured: Change from baseline BAPL at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study startJan 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229186
Sponsor's protocol ID
5752
Acronym
EVOCAD
Status last verified
Jan 2020
First submitted
23 Sep 2019
Last updated
18 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao LN, Long HW, Mu Y, Chew LY. The toxicity of amyloid beta oligomers. Int J Mol Sci. 2012;13(6):7303-7327. doi: 10.3390/ijms13067303. Epub 2012 Jun 13.

    PubMed 22837695

  • Coppola G, Di Renzo A, Ziccardi L, Martelli F, Fadda A, Manni G, Barboni P, Pierelli F, Sadun AA, Parisi V. Optical Coherence Tomography in Alzheimer's Disease: A Meta-Analysis. PLoS One. 2015 Aug 7;10(8):e0134750. doi: 10.1371/journal.pone.0134750. eCollection 2015.

    PubMed 26252902

  • Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.

    PubMed 3496763

  • Jack CR Jr, Holtzman DM. Biomarker modeling of Alzheimer's disease. Neuron. 2013 Dec 18;80(6):1347-58. doi: 10.1016/j.neuron.2013.12.003.

    PubMed 24360540

  • Caminiti SP, Ballarini T, Sala A, Cerami C, Presotto L, Santangelo R, Fallanca F, Vanoli EG, Gianolli L, Iannaccone S, Magnani G, Perani D; BIOMARKAPD Project. FDG-PET and CSF biomarker accuracy in prediction of conversion to different dementias in a large multicentre MCI cohort. Neuroimage Clin. 2018 Jan 28;18:167-177. doi: 10.1016/j.nicl.2018.01.019. eCollection 2018.

    PubMed 29387532

Questions about this trial

What is this clinical trial studying?

A study testing EVOO-C and ROO in people with Neurodegenerative Diseases, run by University of Bari Aldo Moro.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the change of cerebral performance after olive oil supplementation. (time frame: Change from baseline MMSE score at 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04229186, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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